Trial Outcomes & Findings for Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection (NCT NCT04489381)
NCT ID: NCT04489381
Last Updated: 2024-10-17
Results Overview
Time to Sustained Response is the time in days from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels. NOTE: Data collection ended at study day 21 and \>25% of subjects in each treatment group had not yet achieved Sustained Response (32% in the Nitazoxanide group and 35% in the Placebo group). Therefore, it was impossible to calculate a third quartile for either group. Data presented here imputes "21" as the third quartile. No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
TERMINATED
PHASE3
214 participants
21 days
2024-10-17
Participant Flow
Participant milestones
| Measure |
Nitazoxanide
Two nitazoxanide 300 mg tablets orally twice daily for 5 days
Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
Placebo
Two placebo tablets orally twice daily for 5 days
Placebo: Two placebo tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
110
|
|
Overall Study
COMPLETED
|
101
|
107
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Nitazoxanide
Two nitazoxanide 300 mg tablets orally twice daily for 5 days
Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
Placebo
Two placebo tablets orally twice daily for 5 days
Placebo: Two placebo tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
Baseline characteristics by cohort
| Measure |
Nitazoxanide
n=104 Participants
Two nitazoxanide 300 mg tablets orally twice daily for 5 days
Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
Placebo
n=110 Participants
Two placebo tablets orally twice daily for 5 days
Placebo: Two placebo tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 14.7 • n=99 Participants
|
35 years
STANDARD_DEVIATION 13.9 • n=107 Participants
|
36 years
STANDARD_DEVIATION 14.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
189 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Baseline Illness Severity
Mild Illness
|
73 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Baseline Illness Severity
Moderate Illness
|
31 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Subject Risk Status
At Increased Risk of Complications
|
62 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Subject Risk Status
Not At Increased Risk of Complications
|
42 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Time from Symptom Onset to Randomization
|
39 hours
STANDARD_DEVIATION 15.0 • n=99 Participants
|
40 hours
STANDARD_DEVIATION 15.6 • n=107 Participants
|
39 hours
STANDARD_DEVIATION 15.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: All randomized subjects who received at least one dose of study medication and were positive at Baseline for enterovirus/rhinovirus (EV/RV) infection.
Time to Sustained Response is the time in days from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels. NOTE: Data collection ended at study day 21 and \>25% of subjects in each treatment group had not yet achieved Sustained Response (32% in the Nitazoxanide group and 35% in the Placebo group). Therefore, it was impossible to calculate a third quartile for either group. Data presented here imputes "21" as the third quartile. No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Outcome measures
| Measure |
Nitazoxanide
n=79 Participants
Two nitazoxanide 300 mg tablets orally twice daily for 5 days
Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
Placebo
n=92 Participants
Two placebo tablets orally twice daily for 5 days
Placebo: Two placebo tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
|---|---|---|
|
Time From First Dose to Sustained Response
|
13.5 days
Interval 6.22 to 21.0
|
16.3 days
Interval 7.32 to 21.0
|
SECONDARY outcome
Timeframe: 21 daysPopulation: All randomized subjects who received at least one dose of study medication and were positive at Baseline for enterovirus/rhinovirus (EV/RV) infection. Proportions rounded to the nearest hundredth.
Proportion of subjects requiring systemic antibiotics for an infection secondary to Enterovirus/Rhinovirus. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Outcome measures
| Measure |
Nitazoxanide
n=79 Participants
Two nitazoxanide 300 mg tablets orally twice daily for 5 days
Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
Placebo
n=92 Participants
Two placebo tablets orally twice daily for 5 days
Placebo: Two placebo tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
|---|---|---|
|
Proportion of Subjects Requiring Systemic Antibiotics
|
0.03 proportion of participants
|
0.07 proportion of participants
|
Adverse Events
Nitazoxanide
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nitazoxanide
n=104 participants at risk
Two nitazoxanide 300 mg tablets orally twice daily for 5 days
Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
Placebo
n=110 participants at risk
Two placebo tablets orally twice daily for 5 days
Placebo: Two placebo tablets administered orally twice daily with food for 5 days
Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
3/104 • Number of events 3 • 28 days
|
2.7%
3/110 • Number of events 3 • 28 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/104 • 28 days
|
2.7%
3/110 • Number of events 3 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place